Batch Release and Stability Studies

Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products. We develop a specific program to meet all requirements necessary including stability storage conditions and determining the relevant experiments needed according to the industry guidances. At the completion of each project, we provide customers with certificate of analysis and stability reports.

Contact Us

Request A Quote

Interested in speaking with us about our development services, or receiving a quote?
Contact Us

Batch Release and Stability Studies

Instrumentation

  • Next Generation Impactor

  • Andersen Cascade Impaction

  • Unit Dose Sampling Apparatus

  • Copley Critical Flow Controller

  • SprayView (spray characterization)

  • Malvern Spraytec

  • Automated actuation systems

  • Polarized light microscope

  • Breath simulator

  • Karl Fischer

  • FTIR

  • Waters HPLC systems

  • GC-MS

  • GC-HS

  • LC-MS

Download Now

Download Services Brochure

Want to review our Development Services for DPIs, MDIs, Nebulizers, and Nasal Sprays in more detail? Download our services brochure.
Download Now

Qualifications

  • cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA

  • Registered with FDA (last inspection January 2016 – no 483s)

  • DEA license for controlled drug substances (schedule II-V)

  • Subject matter experts in:

    • Analytical chemistry
    • Inhalation physical tests
    • Spray characterization
    • Particle size analysis

Regulatory Experience

We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.

  • US (FDA)

  • EU (European Medicines Agency) & Australia

  • Canada (Health Canada)

  • Americas

  • India

Learn More